FDA 510(k) Application Details - K160349

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K160349
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Guangdong Biolight Meditech Co., Ltd. Innovation First Road, Technical Innovation Coast Zhuhai 519085 CN Other 510(k) Applications for this Company
Contact	Liang Jin Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2016
Decision Date	11/03/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review